Pre-Clinical Experimental Results

Pre-Clinical Resultsadmin2020-10-20T20:37:43+00:00

A 2-year pre-human trial was performed in rats. It was determined that:

• Distribution of cells: Widespread throughout the ventricular system and parenchyma

• Safety: No cellular damage, immune response, obstruction of cerebrospinal fluid circulation, neoplasia or aberrant growth of administered cells.

Proof in the rat model that the injection reaches all ventricles of the brain, and human mRNA injected cells migrate into the parenchyma of the brain through these ventricles.

CEREWiNT® Phase 1 Clinical Safety Trial

Hoag Hospital – Newport Beach

The basic outline of our protocol is simple. Here are the steps a Participant will go through:

To be enrolled in Regeneration Biomedical’s Phase 1 Safety Trial for CEREWiNT®, a Participant must first be diagnosed by a physician to have Alzheimer’s disease and confirmed to meet all the Inclusion/Exclusion Criteria found on the Inclusion/Exclusion Criteria Page.
A Participant must have a designated caregiver that will help them get to and from their appointments and procedures. The Caregiver Inclusion/Exclusion Criteria can also be found on the Inclusion/Exclusion Criteria Page. All participants will meet with a physician or study coordinator and be given information regarding any risks, as well as a detailed explanation of all tests and procedures involved in the study and be required to give their own Informed Consent.
Once a Participant has been qualified as eligible, the participants will have their own personal fat cells collected via a lipoaspirate procedure (also known as liposuction – removing fat from the abdominal area) for processing. This will be done as an outpatient procedure at the Hoag Pavilion and will take about 1 hour. During processing, specific stem cells will be selected in a special (proprietary) way and prepared for the next steps. The cell processing takes about 4-6 weeks and at that point the finished product is called “CEREWiNT®”.
An Ommaya Reservoir will need to be implanted (if the Participant doesn’t already have one). An Ommaya reservoir is a flat-bottomed domed bubble which is implanted below the scalp. The reservoir is connected to a catheter which is placed into the hollow cavities of the brain through a hole made in the skull. Implantation of the Ommaya Reservoir and catheter is done via a brief outpatient surgical procedure which takes about 30 minutes.
About 8 weeks after collection, the cells will have been completely processed and will be ready for implantation. The Participant will come into the hospital or infusion center and have the reservoir area of their scalp prepped/sterilized for the procedure. After the Participant’s scalp is prepped, a surgeon will insert a small needle into the Ommaya Reservoir and draw out a small amount of cerebrospinal fluid. The surgeon will then inject the CEREWiNT® into the Ommaya Reservoir after which small amount of the cerebrospinal fluid that was drawn out will be used to flush the Ommaya Reservoir and get as much of the CEREWiNT® into the ventricles of the brain as possible. This entire procedure takes less than 30 minutes.***
The Participant will remain in the hospital over-night, be monitored for 24 hours, and have a next day visit with their surgeon.
The Participant will be monitored and tested for the next 52 weeks. This is a Phase 1 safety only trial. Each Participant will receive only one injection and safety will be assessed.
This Phase 1 Safety Trial lays the groundwork for Phase 2 efficacy trial. Participants in Phase 1 may have the option of rolling over into a parallel treatment group to the Phase 2 trial.
This document is for information purposes only; a more thorough informed consent will be given to the Participant prior to the start of the trial, for signature.

*** It is important to understand that there are risks involved in any safety trial. Some of the risks include bleeding, swelling, infection, discomfort, headache, and the possibility of additional surgery to name a few. A complete list of potential risks will be provided and completely explained to potential participants.

Inclusion Criteria